vutrisiran (Amvuttra)

following a full submission:

vutrisiran sodium (Amvuttra®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

SMC restriction: as monotherapy for the treatment of adult patients with wild-type or hereditary ATTR-CM.

In a phase III study, treatment with vutrisiran monotherapy significantly reduced the risk of all-cause mortality and recurrent cardiovascular events compared with placebo in patients with wild-type or hereditary ATTR-CM. There are limited data to support an indirect comparison of vutrisiran and tafamidis.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.